AAB MLE offers prompt, knowledgeable customer service including experienced laboratory professionals to assist you with your regulatory questions. Call AAB MLE Customer Service, or e-mail us at mle@aab-mle.org, if you have any questions about laboratory regulations or other laboratory-related questions not listed below.
CLIA Regulations
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing performed on humans in the U.S. through CLIA. CLIA covers approximately 320,000 non-research laboratories that fall under their oversight and are subject to CLIA standards and requirements. Although CLIA is a federal program, CMS State Agencies are responsible for laboratory oversight and maintaining CLIA certification records. Some states also have laboratory licensing laws separate from the CLIA regulations, so please check with your State before your lab begins testing. The main goal of the CLIA program is to ensure quality laboratory testing.
Accrediting Agency Websites
Additional Resources
Regulatory
- OSHA Bloodborne Pathogens Requirements
- CLIA and Your Laboratory
- CLIA Proficiency Testing DOs and DON’Ts
- G2’s National Intelligence Report (Note: MLE offers this publication at a discounted rate for participants. Enroll in module 142.)